Combating Related Epidemics in HCV

Phase 4Not Yet RecruitingNCT07560046

Duke University1,280 enrolled

Overview

This is a two-arm cluster randomized control trial to evaluate the effectiveness of a single-visit point-of-care (POC) test and treat bundle (intervention arm) compared to the current standard-of-care (SOC, control arm). 1:1 randomization occurs at the site level.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,280

Conditions

HIV - Human Immunodeficiency Virus Hepatitis B Virus (HBV)HEPATITIS C (HCV)

Interventions

Cepheid GeneXpert HCV TestDEVICE

Cepheid Xpert HCV Test, performed on the GeneXpert Xpress system, in an automated in vitro reverse transcription polymerase chain reaction (RT-PCR) test for the qualitative detection of Hep C (HCV) RNA in human fingerstick.

Abbott Determine HIV - 1/2 Ag/AbDEVICE

Abbott Determine HIV - 1/2 Ag/Ab combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of Human Immunodeficiency Virus type-1 (HIV-1) p24 antigen (Ag) and antibodies (Ab) to HIV type-1 and type-2 in fingerstick. Intended use is point-of-care test to aid in the diagnosis of infection.

Abbott Determine HbsAg 2DEVICE

Determine HBsAg 2 is an in vitro, visually read, qualitative immunoassay for detection of Hepatitis B Surface Antigen (HBsAg) in human fingerstick. The test is intended as an aid to detect HBAg from infected individuals.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Can provide written informed consent or assent 2. Minimum of 16 years of age 3. Willing to undergo HIV, HCV, HBV testing 4. Willing to undergo treatment for HCV and complete study activities Exclusion Criteria: 1. History of HCV treatment for current infection 2. Known preexisting (evidence or history of) decompensated liver disease based on: medical diagnosis through medical record, reporting by the participant, or clinical evidence per the site PI 3. Contraindication for treatment with sofosbuvir/velpatasvir due to allergy or drug-drug interaction including use of any prohibited concomitant medications within 28 days prior to study entry. 4. History of clinically significant illness or any other major medical disorder that may interfere with participant treatment, assessment, or compliance with study requirements as determined by the site PI 5. Ongoing need for use of daily proton pump inhibitor (PPI) at doses ≥40 mg of omeprazole (or equivalent). NOTE: PPI can be discontinued or dose reduced to 20 mg/day of omeprazole (or equivalent) at time of study entry. Retreatment Inclusion Criteria: 1. Completion of sofosbuvir/velpatasvir treatment regimen as enrolled participant in CREST and willingness to receive retreatment. FIB-4 \& CTP score available within 90-days of retreatment initiation. 2. Meeting any of the below criteria during post-cessation treatment follow-up. Relapse, defined as HCV RNA \<LLOQ/D (TD or TND) during and/or at end of treatment followed by HCV RNA \>LLOQ/D or target detected based on qualitative POC test at any time point from end of treatment to 12 weeks after end of treatment OR Re-infection, defined as meeting the primary outcome criteria for SVR4+ followed by HCV RNA \>LLOQ/D or target detected based on qualitative POC test at any time point beyond meeting SVR4+ OR Post-treatment virologic failure, defined as HCV RNA \>LLOQ/D at any point after end of treatment (after week 24 visit) or during follow-up, not otherwise meeting definition of relapse or re-infection Retreatment Exclusion Criteria: 1. Known preexisting (evidence or history of) decompensated liver disease based on: medical diagnosis through medical record, reporting by the participant, clinical evidence per the site PI, or by CTP score ≥7. 2. Pregnant or breast feeding at time of retreatment with sofosbuvir/velpatasvir/voxilaprevir. 3. Contraindication for treatment with sofosbuvir/velpatasvir (reinfection) or sofosbuvir/velpatasvir/voxilaprevir (relapse or virologic failure) due to FDA package insert, allergy, or drug-drug interaction including use of any prohibited concomitant medications within 28 days prior to study entry. 4. History of clinically significant illness or any other major medical disorder that may interfere with participant treatment, assessment, or compliance with study requirements as determined by the site PI 5. Ongoing need for use of daily proton pump inhibitor (PPI) at doses ≥40 mg of omeprazole (or equivalent.). NOTE: PPI can be discontinued or dose reduced to 20 mg/day of omeprazole (or equivalent) at time of study entry.

Outcomes

Primary Outcomes

Proportion of participants who complete the Hepatitis C Virus (HCV) care cascade within 24 weeks of study entry in intervention versus Standard of Care (SOC) arm.

Proportion of participants in the primary analysis population (as defined as detectable HCV RNA on dried blood spot testing at screening) who complete the HCV care cascade within 24 weeks of study entry in intervention versus SOC arm. Completion of the care cascade will be defined as HCV RNA\<lower limit of quantification/detection (LLOQ/D) at a minimum of 4 weeks post-cessation of direct-acting antiviral (DAA) therapy sustained virologic response (SVR4+).

Time frame: 24 weeks from study enrollment

Secondary Outcomes

Proportion of participants initiating same-visit direct-acting antiviral (DAA) treatment following enrollment (intervention arm only)

Proportion of participants initiating same-visit DAA treatment following enrollment (intervention arm only)

Time frame: Day 1

Proportion of participants initiating direct-acting antiviral (DAA) therapy within 12 weeks of entry

HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.

Time frame: 12 weeks

Proportion of participants initiating direct-acting antiviral (DAA) therapy within 24 weeks of entry

HCV related \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\].

Time frame: 24

Time from enrollment to treatment initiation

HCV related \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\].

Data from ClinicalTrials.gov

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Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]DRUG

Participants with detectable HCV RNA on Xpert test will receive sofosbuvir/velpatasvir at the same visit as the POC test in the intervention arm. Participants in the SOC arm will receive sofosbuvir/velpatasvir after standard of care testing and treatment assessment has been completed.

Time frame: up to 24 weeks

Proportion of participants completing direct-acting antiviral (DAA) therapy within 24 weeks of entry

HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.

Time frame: 24 weeks

Proportion of participants achieving sustained virologic response (SVR4+) within 60 weeks of entry

HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.

Time frame: 60 weeks

Cumulative incidence of HCV reinfection following sustained virologic response (SVR4+) within 60 weeks of entry

HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.

Time frame: within 60 weeks

Cumulative retreatment following sustained virologic response (SVR4+) or relapse within 60 weeks of entry

HCV related \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\]. This analysis for retreatment is limited to participants 18 years old and older.

Time frame: within 60 weeks

Proportion of participants with HCV RNA not detected based on dried blood spot at week 24 and week 60

HCV related \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\].

Time frame: Week 24 and 60

Proportion of participants who have received any HIV test result within 24 weeks of entry

HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.

Time frame: 24 weeks of entry

Proportion of participants who initiate PrEP within 24 weeks of entry

HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.

Time frame: 24 weeks of entry

Proportion of participants with HIV who commence direct-acting antiviral (DAA) therapy within 24 weeks of entry

HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.

Time frame: 24 weeks of entry

Proportion of participants with HIV not on antiretroviral therapy (ART) at screening who commence ART within 24 weeks of entry

HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.

Time frame: 24 weeks of entry

Proportion of participants with HIV on antiretroviral therapy (ART) at screening who remain on ART at week 24 and week 60

HIV related \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\].

Time frame: Week 24 and 60

Time from enrollment to PrEP initiation

HIV related \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\].

Time frame: up to 60 weeks

All cause and liver specific hospitalizations through week 60